Topogyne 400microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Misoprostol

Available from:

Nordic Pharma Ltd

ATC code:

G02AD06

INN (International Name):

Misoprostol

Dosage:

400microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07010100; GTIN: 08718481142301

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
Topogyne 400 microgram tablets
Misoprostol
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed in this
leaflet.
What is in this leaflet
:
1.
What Topogyne is and what it is used for
2.
What you need to know before you take Topogyne
3.
How to take Topogyne
4.
Possible side effects
5.
How to store Topogyne
6.
Contents of the pack and other information
1.
What Topogyne is and what it is used for
Topogyne tablets contain misoprostol, which is similar to a chemical
substance called ‘prostaglandin’ that
your body produces naturally. Misoprostol triggers contractions of the
womb and softens the cervix.
Topogyne is used after taking another medicine called mifepristone for
termination of pregnancy. It should
be taken no later than 49 days after the first day of your last
menstrual period.
2.
What you need to know before you take Topogyne
Do not take Topogyne
-
if you are allergic to misoprostol, any other prostaglandin or any of
the other ingredients of this
medicine (listed in section 6)
-
if the pregnancy has not been confirmed by ultrasound scan or
biological tests
-
if the first day of your last period was more than 49 days (7 weeks)
ago
-
if your doctor suspects an ectopic precnancy (the egg is implanted
outside the womb)
-
if you cannot take mifepristone (mifepristone is used in combination
with Topogyne)
Warnings and precautions
Talk to your doctor before taking Topogyne
-
if you have liver or kidney disease
-
if you suffer from anaemia or malnutrition
-
if you have cardiovascular disease (heart or circulatory disease)
-
if you are a

Summary of Product characteristics

OBJECT 1
TOPOGYNE 400 MICROGRAM TABLETS
Summary of Product Characteristics Updated 28-Mar-2014 | Exelgyn
1. Name of the medicinal product
Topogyne 400 microgram tablets
2. Qualitative and quantitative composition
One tablet contains 400 microgram misoprostol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White, round, flat tablets, with a diameter of 11 mm and thickness of
4.4 mm, with "M400" engraved on
one side.
4. Clinical particulars
For termination of pregnancy, the anti-progesterone mifepristone and
the prostaglandin analogue
misoprostol can only be prescribed and administered in accordance with
the countries national laws and
regulations.
4.1 Therapeutic indications
Medical termination of developing intra-uterine pregnancy, in
sequential use with mifepristone, up to 49
days of amenorrhea (see section 4.2).
Misoprostol is indicated in adults.
4.2 Posology and method of administration
Posology
Misoprostol is taken as a single 400 microgram oral dose 36 to 48
hours after taking a single 600 mg oral
dose of mifepristone. Information on the posology of mifepristone can
be found in the product
information of mifepristone.
Vomiting within 30 minutes after the intake could lead to a decrease
in misoprostol efficacy: oral intake
of a new misoprostol 400 microgram tablet is recommended in this case.
Paediatric population
Only limited data is available on the use of misoprostol in
adolescents.
Method of administration
Misoprostol tablets are FOR ORAL USE ONLY and should not be
administered by any other route of
administration.
4.3 Contraindications
- Hypersensitivity to misoprostol or other prostaglandins, or to any
of the excipients listed in section 6.1
- Pregnancy not confirmed by ultrasound scan or biological tests
- Suspected ectopic pregnancy
- Contraindication for mifepristone
- Pregnancy beyond 49 days of amenorrhea
As misoprostol is used in combination with mifepristone, please refer
to the contraindications for this
mifepristone as well.
4.4 Special warnings and precautions